Catalog Number

3158544

Brand Name

Impulse 7010

Version/Model Number

IMPULSE 7010

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K083347

Product Code

DRL

Product Code Name

Tester, Defibrillator

Public Device Record Key

4f2850a5-7a3e-4f1c-be85-b3b3d7d9571c

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

May 24, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-